Content about Branded

SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.

Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.

NEW BRUNSWICK, N.J. — Johnson & Johnson posted decreases in sales for fourth quarter 2010 and for the year, according to an earnings statement released Tuesday.

Sales for the quarter were $15.6 billion, a 5.5% decrease from fourth quarter 2009’s $16.5 billion. Sales for the year were $61.6 billion, down by 0.5% from $61.9 billion in 2009.

Meanwhile, profits for the quarter were $1.9 billion, a 12% decrease from $2.2 billion in fourth quarter 2009. Profits for the year were $13.3 billion, an 8.7% increase over $12.3 billion in 2009.

MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.

NEW YORK — A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

U.S. drug maker Forest Labs and French drug maker Pierre Fabre Medicament said that while the overall difference between patients treated with levomilnacipran and those treated with the placebo was not statistically significant, the drug consistently demonstrated improvement relative to the placebo over the course of the phase-3 trial.

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

THOUSAND OAKS, Calif. — German drug maker Boehringer Ingelheim will purchase a manufacturing plant from U.S. biotech company Amgen, the two said.

The plant, located in Fremont, Calif., is 100,000 sq. ft. and employs around 360 people. BI has been a contract manufacturer for Amgen for more than 10 years. Financial terms of the deal were not disclosed, though BI said it would purchase “substantially all” of the assets at the plant.

SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for head lice, the agency said Tuesday.

The FDA approved Natroba (spinosad) topical suspension, made by ParaPro, a privately owned drug company based in Carmel, Ind. The drug is used to treat head lice infestation in patients ages 4 years and older.

THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.